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NCT00349778 · ADVERSE EVENTS

Adverse events

High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma · Source last updated 2017-12-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
High-Dose Sequential Therapy

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

5 / 1020 / 10222 / 102

Group identifiers: EG000: High-Dose Sequential Therapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Cardiogenic shock
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Fungal infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    aspergillus infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Interstitial pneumonitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    event Groups
    1. deaths Num Affected
      22
      deaths Num At Risk
      102
      description
      Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      102
      serious Num Affected
      5
      serious Num At Risk
      102
      title
      High-Dose Sequential Therapy
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        102
        num Events
        1
      term
      Cardiogenic shock
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        102
        num Events
        1
      term
      Fungal infection
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        102
        num Events
        1
      term
      aspergillus infection
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        102
        num Events
        1
      term
      Interstitial pneumonitis
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        102
        num Events
        1
      term
      Infection
    time Frame
    2 years

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice